Every Word Counts! Or Does it?
FDA is finalizing its 2012 Proposed Rule and amending the regulations relative to certain Citizen Petitions. While the revisions mostly pertain to section 505(q) Petitions (originally created under the Food and Drug Administration Amendments Act of 2007 [FDAAA]), the Agency is (in at least one instance) broadening the mandatory certification requirements for certain Petitions. The […]